Between 2% and 3% of women are born with one or both nipples congenitally inverted. An inverted nipple is caused when the lactiferous ducts are shorter than normal exerting traction on the center of the nipple and preventing the nipple from protruding forward of the nipple-areola complex to assume the more classic everted shape. Congenital inverted nipples are to be distinguished from the inversion of a nipple that was previously normal; such inversion can be caused by abnormal growth within the breast tissue including cancerous tumors. Congenitally inverted nipples are not thought to be susceptible to pathology but have been known to complicate breast feeding in view of it being harder to for a newborn to latch on to the nipple and therefore make breast feeding more difficult for both mother and baby. Similarly, non-lactating women may desire to correct congenitally inverted nipples for purely cosmetic reasons.
Surgical techniques exist to correct congenitally inverted nipples, but these engender all the risks and expense associated with surgery included, but not limited to infection, and complications associated with anesthesia. These surgical corrections also carry the essential added complication of interrupting normal anatomy of the lactiferous ducts rendering the ducts incapable of normal lactation.
Breast cancer is the most common cancer in women and successful treatment for breast cancer hinges primarily on the stage at which the cancer is detected. The current screening techniques, mammography and physical exam, are severely limited by their ability to detect breast pathology until the cancerous growth has reached at least one or more often two centimeters in size. Eighty to ninety percent of breast cancers arise in the intraductal epithelial cells of the breast making nipple aspirated fluid (NAF) from these ducts an ideal sample for the early detection of cancerous transformation. Such fluid yields cytology samples, as well as cell products which are subject to analysis providing an indicator of cancerous transformation of previously healthy tissue including cell proliferation markers, oncogenes, growth factors and growth factor receptors, angiogenic factors, proteases, adhesion factors and tumor suppressor genes. Research on NAF is ongoing and rapidly expanding, and the list of markers will continue to expand as well.
Numerous devices exist both for the application of a partial vacuum to an inverted nipple or the collection of NAF. Those devices which are designed for the eversion of nipples have bulky designs or structures which are complicated and/or difficult to use. Those devices for collecting NAF are used by clinicians in a clinical setting and are designed such that the patient's experience of having NAF collection is unacceptably distasteful or uncomfortable.
Patents and publications describing devices for the correction of inverted nipples or the collection of NAF fluid include: Pre-Grant Publications 2004/0176707, 2002/0072702, 2001/0031911, U.S. Pat. Nos. 6,712,785, 6,689,073, 6,500,112, 6,287,521, 6,210,360, 6,010,466, 5,871,456, 5,798,266, 5,947,923, 5,520,613, 3,786,801, 2,120,872, 1,922,947, 1,509,226, 897,289, 29,662 and 11,623; and WO's 03/017912 and 96/29043, British Patent Applications 2,325,411 and 2,240,924, and European Patent Application No. 0 442 758.